Connector Assemblies for Implantable Medical Electrical Systems

ABSTRACT

A device connector assembly includes a plurality of electrical contacts and a sealing member including a corresponding plurality of apertures; each electrical contact extends within a corresponding aperture of the plurality of apertures such that each contact is accessible for coupling with a corresponding connector element of a lead connector. The lead connector elements protrude from a first side of an insulative substrate of the lead connector, and may be coupled to the contacts of the device connector assembly by aligning each connector element with the corresponding aperture of the sealing member, and applying a force to a second side of the insulative substrate, opposite the first side, in order to press each connector element into engagement with the corresponding contact.

TECHNICAL FIELD

The present disclosure pertains to implantable medical electricaldevices and systems, and more particularly to connector assembliesemployed by the devices and systems.

BACKGROUND

Implantable neuromodulation systems can provide electrical stimulationfor the treatment of pain and/or various neurological disorders.Neuromodulation systems typically include a plurality of stimulationelectrodes which may be implanted at specific sites along a spinal cord,a peripheral nerve, or in a brain of a patient; the plurality ofelectrodes are typically mounted to an elongate lead body which carriescorresponding conductors for electrical coupling of the electrodes to aneuromodulation device. Electrical coupling to the device isaccomplished via connector elements terminating each conductor at a leadconnector, which is configured to mate with a corresponding connectorport of the neuromodulation device.

In recent years, new models of neuromodulation systems have beendeveloped for increased functionality, for example, in providingstimulation from an increasing number of lead electrodes. In order toaccommodate the increased functionality, while keeping a bulk of theseimplantable systems to a minimum, for patient comfort, there is a needfor miniaturization of system components and higher density arrangementsof these components without sacrificing system handling and reliability.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings are illustrative of particular exemplaryembodiments and therefore do not limit the scope of the invention. Thedrawings are not to scale (unless so stated) and are intended for use inconjunction with the explanations in the following detailed description.Disclosed embodiments will hereinafter be described in conjunction withthe appended drawings, wherein like numerals denote like elements.

FIG. 1 is a schematic of a human body showing various general implantlocations for implantable neuromodulation systems.

FIG. 2 is a portion of an exemplary neuromodulation system, according tosome embodiments of a first group of embodiments.

FIG. 3 is a portion of an exemplary neuromodulation system, according tosome embodiments of a second group of embodiments.

FIG. 4A is a cross-section view of a device connector assembly, throughsection line A-A of FIG. 2, according to some embodiments.

FIG. 4B is an exploded perspective view of the connector assembly shownin FIG. 4A.

FIG. 4C is a perspective view of a portion of the connector assemblyshown in FIGS. 4A-B.

FIG. 4D is a detailed perspective view of an electrical contact from theassembly shown in FIGS. 4A-C, according to some embodiments.

FIG. 4E is a perspective view of a medical electrical lead connectorportion of the system shown in FIG. 2, according to some embodiments.

FIG. 4F is a schematic representative of conductor routing for the leadconnector portion shown in 4E, according to some embodiments.

FIG. 5A is a cross-section view of a device connector assembly, throughsection line B-B of FIG. 3, according to some embodiments.

FIG. 5B is an exploded perspective view of the connector assembly shownin FIG. 5A.

FIG. 5C is an elevation view of the connector assembly shown in FIGS.5A-B, according to some embodiments.

FIG. 5D is a perspective view of a lead connector positioned andconfigured for insertion into the connector assembly shown in FIGS.5A-C.

FIG. 5E is a schematic representation of conductor routing for the leadconnector shown in FIG. 5D, according to some embodiments.

FIG. 6A is a perspective view of an electrical contact, according tosome alternate embodiments.

FIG. 6B is a plan view of a sheet metal piece from which the contactshown in FIG. 6A may be formed.

FIG. 6C is an elevation view of the contact shown in FIG. 6A.

FIG. 6D is an end view of the contact shown in FIG. 6A.

FIG. 7A is an exploded perspective view of a device connector assemblyand portions of a pair of medical electrical leads, according to somealternate embodiments in a third group of embodiments.

FIG. 7B is a detailed perspective view of a portion of the connectorassembly shown in FIG. 7A.

FIG. 7C is a perspective view of a medical electrical lead connector,according to some alternate embodiments.

FIG. 7D is a longitudinal section view through the device connectorassembly of FIGS. 7A-B.

DETAILED DESCRIPTION

The following detailed description is exemplary in nature and is notintended to limit the scope, applicability, or configuration of theinvention in any way. Rather, the following description providespractical illustrations for implementing exemplary embodiments of thepresent invention. Examples of constructions, materials, dimensions, andmanufacturing processes are provided for selected elements, and allother elements employ that which is known to those of skill in the fieldof the invention. Those skilled in the art will recognize that many ofthe examples provided have suitable alternatives that can be utilized.

FIG. 1 is a schematic plan view of a human body showing various generalimplant locations 1, 2, 3 for portions of implantable neuromodulationsystems; and FIGS. 2 and 3 are perspective views of portions ofneuromodulation systems 200, 300 according to two groups of embodiments.FIG. 1 illustrates location 1 encompassing a pectoral region and a neckregion, which extends behind the ears, around the base of the skull, andwithin which a pocket may be formed for a neuromodulation device, forexample one of devices 210, 310, from which a lead may extend forstimulation of peripheral nerves, either within or adjacent the region,or for deep brain stimulation. FIG. 1 illustrates location 2encompassing an abdominal and buttock region, within which a pocket maybe formed to hold a neuromodulation device, from which one or more leadsmay extend for stimulation of peripheral nerves, either within oradjacent the region, or for spinal cord simulation. FIG. 1 illustrateslocation 3 encompassing an upper thigh region, within which a pocket maybe formed to hold a neuromodulation device, from which one or more leadsmay extend for stimulation of peripheral nerves, either within oradjacent to the region.

FIGS. 2 and 3 illustrate systems 200, 300 each including a medicalelectrical lead 240 and 340, respectively. According to the illustratedembodiments, leads 240 and 340 are extension leads for other medicalelectrical leads that include stimulation electrodes, which are notshown; however, it should be appreciated that, according to alternateembodiments, leads 240 and 340 themselves may extend over a longerlength and include stimulation electrodes. The use of extension leads inneuromodulation systems is well known to those skilled in the art. FIGS.2 and 3 further illustrate each device 210 and 310 including a connectorassembly 220, 320, respectively, which is mounted to a housing 201, 301of each device, and to which the corresponding lead 240, 340 is coupled,according to two groups of embodiments. Each of leads 240, 340 is shownincluding a distal connector port 32, for coupling with the other leadsincluding electrodes, and a lead body 14 formed by an insulative sheath23, for example, silicone rubber or polyurethane tubing, and a pluralityof conductors 19, for example, MP35N alloy wires, either cabled orcoiled, extending therein from the corresponding connector assembly 220,320 to distal connector port 32. According to the embodiment illustratedin FIG. 2, lead 240 is fixedly coupled to connector assembly 220, while,according to the embodiment illustrated in FIG. 3, lead 340 isreversibly coupled to connector assembly 320.

FIG. 4A is a cross-section through section line A-A of FIG. 2; and FIG.4B is an exploded perspective view of connector assembly 220. FIG. 4Aillustrates a connector 42 of lead 240 enclosed within a top seal member47 of connector assembly 220; top seal member 47 may be formed fromsilicone rubber or polyurethane. FIGS. 4A-B illustrate connectorassembly 220 including a plurality of feedthrough assemblies 440,wherein each assembly 440 extends though a corresponding opening 406 ofa feedthrough mount 46 to which a ferrule 413 of each feedthroughassembly 440 is joined, for example, via welding around openings 406.Those skilled in the art will appreciate that mount 46 is formed fromany suitable biocompatible and biostable metal, for example, titanium,is mounted to an opening in housing 201 and may be welded thereto at aflange 419 of mount 46. FIGS. 4A-B further illustrate an insulative base43, for example, formed from a thermoplastic such as PEEK orpolysulfone, which is located within a cavity 414 of mount 46 andsurrounds each feedthrough assembly 440; base 43 supports a plurality ofelectrical contacts 430, wherein each contact 430 is electricallycoupled, via a corresponding feedthrough assembly 440, to electroniccircuitry enclosed within housing 201 of device 210 (FIG. 2). Accordingto the illustrated embodiment, assembly 220 further includes a sealingmember 45, for example, formed from silicone rubber, having a firstsurface 451 mating with base 43, and a second surface 452 mating withtop seal member 47 to electrically isolate each electrical couplingbetween connector 42 and contacts 430; sealing member 45 is shownincluding a plurality of apertures 405, wherein each contact 430 extendsthrough a corresponding aperture 405 and is recessed with respect tosecond surface 452. First surface 451 of sealing member 45 may beadhesively bonded to base 43, for example, with silicone medicaladhesive. According to some preferred methods, a siloxane coating isfirst applied, via a plasma treatment, to base 43, which base 43 ispreferably formed from polysulfone, and then a pre-coat of siliconemedical adhesive, which is thinned in heptane (i.e., approximately a 1:1ratio) is applied to base 43 as a primer for the subsequent bonding ofsealing member 45 thereto with the silicone medical adhesive.

Each feedthrough assembly 440 includes a feedthrough member 410extending through ferrule 413 and surrounded by an insulator element415, for example, a glass or ceramic, known to those skilled in the art,which is hermetically sealed, for example, via a braze joint, known tothose skilled in the art, to feedthrough member 410 and to ferrule 413.Mount 46, ferrules 413 and feedthrough members 410 may each be formedfrom any suitable material, examples of which include, withoutlimitation titanium, niobium, platinum, platinum/iridium, molybdenum,zirconium and tantalum. According to the illustrated embodiment, eachfeedthrough member 410 includes a first part 411, electrically coupledto the corresponding electrical contact 430, a second part 412,extending through a corresponding port 403 of insulative base 43 andaway from the corresponding contact 430, for electrical coupling withinhousing 201, and a bend 401 located between first and second parts 411,412.

FIG. 4C is a perspective view of a portion of connector assembly 220;FIG. 4D is a detailed perspective view featuring one of electricalcontacts 430; and FIG. 4E is a perspective view of lead connector 42.FIG. 4C illustrates an arrangement of contacts 430 in two columns onbase 43 within cavity 414, for example, having been coupled to base 43via insert molding of base about contacts 430. FIG. 4D illustrates theelectrical coupling of each first part 411 of feedthrough member 410 tothe corresponding electrical contact 430. FIG. 4D further illustratescontact 430 including an elongate electrical coupling receptacle 489,which is formed by a groove extending approximately parallel with alongitudinal axis 49 of contact 430; coupling receptacle 489 has a firstportion 483, adapted to receive a connector element 400 of leadconnector 42 (FIG. 4E), and a second portion 493, in which first part411 of feedthrough member 410 extends and to which first part 411 isfixedly coupled, for example, via welding. FIG. 4E illustrates connectorelements 400 coupled to, and protruding from a first side 421 of aninsulative substrate 402 of connector 42, and arranged in two columnsfor alignment and coupling with first portions 483 of electricalcoupling receptacles 489; and FIG. 4C shows mount 46 including anoptional post 460 for mating with an optional aperture 407 of connector42, which may, in an initial assembly of connector 42, facilitate properalignment of connector elements 400 with electrical coupling receptacles489. FIGS. 4B-C further illustrate a relief or cut out portion 416 inmount 46 providing clearance and strain relief for lead body 14 of lead240 at a transition area from connector 42.

According to the illustrated embodiment, each connector element 400includes an approximately cylindrical portion 423 having a longitudinalaxis extending approximately parallel to first side 421 of substrate402, such that, when pressed into electrical coupling receptacle 489,for electrical coupling to the corresponding electrical contact 430, anend 427 of approximately cylindrical portion 423 is adjacent an end 417of fixedly coupled feedthrough member 410. Each element 400 may bepressed into the corresponding electrical coupling receptacle 489 byapplying a force, for example, per arrow C, to a second side 422 ofsubstrate 402. FIG. 4D further illustrates electrical couplingreceptacle 489 of contact 430 formed by first and second sidewalls 431,432, which are opposite one another and extend at an angle away from oneanother; an elongate protrusion 433, for example having a radius ofapproximately 0.002 inch, is shown extending longitudinally along eachsidewall 431, 432. Protrusions 433 create a ‘snap fit’ for insertion ofconnector elements 400 into electrical coupling receptacle 489 andprovide an additional retaining force to secure both connector element400 and feedthrough member 410 within electrical coupling receptacle489. It should be noted that alternate embodiments of the presentinvention need not include protrusions 433 to create such a ‘snap fit’.Furthermore, alternate groove contours may be employed by contacts 430according to alternate embodiments. Configurations of alternateelectrical contact embodiments will be described below, in conjunctionwith FIGS. 6, 7B and 7D. Connector elements 400 and contacts 430 may beformed from any suitable conductive material, examples of which include,without limitation, gold, platinum/iridium, tantalum, titanium, MP35Nalloy, and stainless steel. According to some embodiments, a diameter ofcylindrical portion 423 is approximately equal to a diameter of firstpart 411 of feedthrough member 410, which diameter may be in a rangefrom approximately 0.005 inch to approximately 0.010 inch.

A first force may be applied to press portions 423 of connector elements400 past protrusions 433 and into electrical coupling receptacles 489 ofcontacts 430 for electrical coupling, and a subsequent second, andopposite, force may be applied to lift connector elements 400 out fromelectrical coupling receptacles 489. Each of these forces couldadversely load feedthrough assemblies 440, for example, at interfaces ofinsulator elements 415, were it not for bend 401 formed in eachfeedthrough member 410 between first and second parts 411, 412 thereof.

FIG. 4E further illustrates each connector element 400 further includinga flange 429 extending laterally from the corresponding cylindricalportion 423. According to some preferred embodiments, flanges 429 areembedded in substrate 402, for example, via injection molding, to secureeach connector element 400 to connector 42. If insulative substrate 402of connector 42 is relatively flexible, for example, being formed fromsilicone rubber or polyurethane, flanges 429, being formed from any ofthe aforementioned relatively rigid and conductive materials, or from arelatively rigid plastic, may lend stability to inserting eachcylindrical portion 423 into first portion 483 of electrical couplingreceptacle 489, for example, by pressing, per arrow C, against secondside 422 of substrate 402. Although FIGS. 4B and 4E illustrate substrate402 having approximately planar surfaces, it should be understood thatthese surfaces may be deformable and/or include recessed or protrudingfeatures creating a non-planar contour, according to alternateembodiments.

FIG. 4F is a schematic representative of conductor routing for leadconnector 42, according to some embodiments. FIG. 4F illustrates aplurality of insulated conductors 450 extending within substrate 402;each of conductors 450 is shown coupled to a corresponding electricalcontact 400. Each of conductors 450 may be formed from one or morewires, for example, made from MP35N alloy, which may be either cabled orcoiled, and each of which may be individually insulated with a jacket ofinsulative material, for example, formed from polyimide, PTFE, or ETFE,although substrate 402 may provide the primary isolation betweenconductors 450 so that the insulative jackets are not necessary.Coupling of each of conductors 450 to the corresponding contact 400 maybe accomplished by welding or crimping according to methods known tothose skilled in the art.

As previously described, in conjunction with FIG. 2, lead connector 42is fixedly secured within connector assembly 220, and, with referenceback to FIG. 4B, a method for assembling connector 220 may beappreciated. Once each feedthrough assembly 440 has been joined tofeedthrough mount 46, and mount 46 has been joined to housing 201 (FIG.2), and once base 43 and sealing member 45, for example, being bondedtogether, are assembled into cavity 416 of mount 46, such that eachfeedthrough member 410 is coupled to the corresponding electricalcontact 430, and each contact 430 is surrounded by sealing member 45,lead connector 42 may be coupled to assembly 220 by pressing eachconnector element 400 thereof into the corresponding electrical contact430. Assembly 220 is completed by forming top seal member 47 thereover;top seal member 47 may either be independently formed as a piece partand attached to assembly 220, for example, via adhesive bonding, withsilicone medical adhesive to lead connector 42 and sealing member 45, ormay be over-molded. According to some alternate embodiments, top sealmember 47 may be attached to lead connector 42, before connector 42 iscoupled to assembly 220, or formed as an integral part of lead connector42, for example, as an extension of substrate 402.

Some exemplary embodiments from another group of embodiments, which wasintroduced in conjunction with FIG. 3, will now be described in greaterdetail in conjunction with FIGS. 5A-E. These exemplary embodimentsinclude connector assembly 320 and lead 340, wherein assembly 320 isadapted to allow lead 340 to be connected and disconnected therefrom.

FIG. 5A is a cross-section view of connector assembly 320, throughsection line B-B of FIG. 3, according to some embodiments; FIG. 5B is anexploded perspective view of connector assembly 320; and FIG. 5C is anelevation view of assembly 320, according to some embodiments. FIGS.5A-C illustrate assembly 320 including a lid 587 that may be opened andclosed, per arrow C, via a pivotable attachment 521 to a feedthroughmount 56 of assembly 320; lid 587 is shown including a relatively rigidouter member 58 and a relatively soft top seal member 57, for example,formed from silicone rubber, which may be attached thereto via a pressfit. Outer member 58 of lid 587 may be formed from any relatively rigidbiocompatible and biostable material, either plastic or metal.Feedthrough mount 56, like mount 46, previously described, is formedfrom any suitable biocompatible and biostable metal, for example,titanium, and is mounted to an opening in housing 301 (FIG. 3), forexample, being welded thereto at a shoulder 519 of mount 56. FIG. 5Bfurther illustrates lid 587 including an aperture 502 for mating about apost 560 of mount 56; an internal surface of post 560 may includethreads 565 to receive a fastener 506, whose head may be tightenedagainst a counter-bore 508 of rigid outer member 58 of lid 587 to securelid 587 in a closed position. According to an alternate embodiment,aperture 502 and post 560 may include mating detent features for a snapfit to secure lid 587 in a closed position. FIG. 5A illustrates lid 587in the closed position, and a connector 54 of lead 340 enclosed, sealedand secured within assembly 320 by lid 587, while FIG. 5C illustrateslid 587 in an open position.

Like connector assembly 220, previously described, connector assembly320 includes the plurality of feedthrough assemblies 440, wherein eachfeedthrough assembly 440 extends through a corresponding opening 406 ofmount 56, and each feedthrough assembly 440 includes ferrule 413, joinedto mount 56, feedthrough member 410, coupled to a correspondingelectrical contact 430, and insulator element 415 hermetically sealed toferrule 413 and feedthrough member 410. An insulative base 53 ofconnector assembly 320 supports contacts 430 and includes ports 403 toallow feedthrough members 410 to extend through base 53 for electricalcoupling with contacts 430; the electrical coupling of feedthroughmembers 410 to contacts 430 may be the same as that described, inconjunction with FIG. 4D, for connector assembly 220.

FIGS. 5A-B further illustrate a sealing member 55, for example, formedfrom silicone rubber, of connector assembly 320 including apertures 405extending therethrough from a first surface 551 to a second surface 552thereof, such that sealing member 55, when joined along first surface551 to base 53, surrounds each contact 430 to help isolate eachelectrical coupling between connector 54 and contacts 430. Sealingmember 55 may be joined to base 53 via adhesive bonding, for example,according to the method previously described for assembly 220, inconjunction with FIGS. 4A-B. With reference to FIG. 5A, in conjunctionwith FIG. 5D, contacts 430 may be seen recessed, with respect to secondsurface 552 of sealing member 55, within apertures 405; and, withreference to FIG. 5E, connector 54 may be seen including connectorelements 400, which protrude from a first side 541 of an insulativesubstrate 504 of connector 54, in a similar manner as for lead connector42 (FIG. 4E), so that each connector element 400 of lead connector 54may be pressed into first portion 483 of electrical coupling receptacle489 of the corresponding contact 430 for electrical coupling in asimilar fashion to that described for connector 42 and assembly 220, forexample, by applying a force along a second side 542 of substrate 504.Once coupled, lid 587 is closed over connector 54, and, with referenceto FIG. 5A, it may be appreciated that top seal member 57 of lid 587mates with second side 542 of insulative substrate 504 of connector 54as well as with second surface 552 of sealing member 55 in order tocomplete the isolation of each electrical coupling between connector 54and contacts 430.

With further reference to FIG. 5D, lead connector 54 is shown positionedfor insertion, per arrow D, into assembly 320, via an insertion port 516extending through a relatively rigid sidewall 561 of feedthrough mount56; insulative substrate 504 of lead connector 54 is shown deformed tofit through insertion port 516. According to the illustrated embodiment,substrate 504 is formed from a flexible material, for example, siliconerubber or polyurethane, and, with further reference to FIG. 5E, aschematic representation of conductor routing for connector 54,according to some embodiments, shows conductors 550 of lead connector 54routed away from connector elements 400 so as not to cross over afolding or bending zone 505 of substrate 504. FIG. 5E furtherillustrates bending zone 505 as an area of substrate 504, which has areduced wall thickness to facilitate the bending, according to someembodiments. Once connector 54 has been inserted through port 516,substrate 504 may be opened up into a more planar configuration, forexample, as illustrated in FIGS. 5A-B and 5E, and as represented withdashed lines in FIG. 5C, for alignment of connector elements 400 overelectrical contacts 430 of assembly 320. According to alternateembodiments, a cross-sectional area of insertion port 516 is sized toallow passage of connector 54 therethrough without deformation ofsubstrate 504.

FIGS. 5B and 5D further illustrate connector 54 including an alignmentaperture 507 extending through substrate 504, in proximity to a proximalend 503 of connector 54, which aperture 507, once connector 54 has beeninserted through port 516, may be mated with post 560 of mount 56, asillustrated, with dashed lines, in FIG. 5C. Alignment aperture 507 mayhelp to align each connector element 400 with electrical couplingreceptacle first portion 483 of the corresponding contact 430, therebyfacilitating proper coupling of connector 54 within connector assembly320. With reference to FIGS. 5C-D, it may be appreciated that alocation, adjacent to insertion port 516, of pivotable attachment 521for lid 587, provides for a lifting of lid 587 in a direction thatleaves ample clearance for grasping of connector 54, once connector isinserted through port 516, in order to properly align connector 54 overelectrical contacts 430, whose electrical coupling receptacles 489 areexposed by opened lid 587. The location of pivotable attachment 521 alsoprovides for clearance to press connector 54 against contacts 430, inorder to insert each connector element 400 into first portion 483 ofelectrical coupling receptacle 489 of the corresponding electricalcontact 430. After connector 54 is fully inserted for electricalcoupling, lid 587 may be closed and secured over connector 54 aspreviously described. If and when device 310 (FIG. 3) needs to beexchanged for a new device, lid 587 may be re-opened to expose leadconnector 54 for disconnection therefrom; to disconnect connector 54, aportion of substrate 504, that is adjacent to proximal end 503, may belifted away from, or ‘peeled’ back from, contacts 430 in order toseparate each connector element 400 out from electrical couplingreceptacle 489 of the corresponding electrical contact 430.

Turning now to FIGS. 6A-D, an electrical contact 630, according to somealternate embodiments, is shown. Contact 630 may be incorporated as asubstitute for any or all of contacts 430, within either of thepreviously described connector assemblies 220, 320, being supported bybase 43, 53, respectively. FIGS. 6A-D illustrate electrical contact 630including an elongate electrical coupling receptacle 689; couplingreceptacle 689 includes a first portion 683 and a second portion 693,each of which portions 683.693 extends approximately parallel with alongitudinal axis 69 of contact 630. FIG. 6A further illustrates firstportion 683 formed by first and second opposing sidewalls 631 and 632,respectively, and second portion 693 likewise formed by third and fourthopposing sidewalls 633 and 634, respectively. Each sidewall 631, 632,633, 634 is shown including first and second protrusions 601, 602, whichextend within coupling receptacle 689 and are offset from one another ina direction approximately orthogonal to longitudinal axis 69. Accordingto the illustrated embodiment, one of first and second portions 683, 693may receive a connector element of a lead connector, for example,connector element 400 of either of lead connectors 42, 54 (FIGS. 4E,5E), and the other first and second portions 683, 693 may receive afeedthrough member, for example, first part 411 of feedthrough member410, fixedly coupled thereto.

With further reference to FIG. 6A, electrical contact 630 also includesfirst and second tabs 671, 672, in which first and second openings 681,682, respectively, are formed. According to the illustrated embodiment,the one of first and second openings 681, 682, which is adjacent to thatportion, 683 or 693, to which feedthrough member 410 is fixedly coupled,may be aligned with one of ports 403 of either of insulative bases 43,53 to allow passage of second part 412 of feedthrough member 410therethrough (FIGS. 4B and 5B). The other of first and second openings681, 682 may then be used for securing contact 630 to either of bases43, 53, for example, via a fastening element 781 extending therethrough,which will be described in more detail below, in conjunction with FIGS.7A-B.

According to exemplary embodiments, contact 630 is made from MP35N sheetmetal, which has a thickness of approximately 0.0025 inch and has beenstamped, or otherwise formed, into the shape shown in FIG. 6B. Referringnow to FIGS. 6C-D, which are an elevation and an end view, respectively,of contact 630, some exemplary dimensions of contact 630 will bedefined. With reference to FIG. 6C a spacing S between first portion 683and second portion 693 of coupling receptacle 689 may be approximately0.02 inch, a length L of each portion 683, 693 may also be approximately0.02 inch, and an overall height H of contact 630 may be approximately0.04 inch. With reference to FIG. 6D, a minimum relaxed gap g betweensidewall 631 and sidewall 632, and between sidewall 633 and sidewall634, for example, between opposing protrusions 602, may be approximately0.0060 inches, while a relaxed gap G, between each of the aforementionedopposing sidewalls, in between protrusions 601 and 602 may beapproximately 0.0077 inch.

FIG. 7A is an exploded perspective view of a device connector assembly720, which may be mounted to a device housing, for example, housing 310,in a manner similar to that described for connector assemblies 220 and320 (FIGS. 2, 3, 4A and 5A); and FIG. 7B is a detailed perspective viewof a portion of assembly 720. Device connector assembly 720 isrepresentative of alternate exemplary embodiments in which either ofcontacts 430, 630 may be incorporated, although FIGS. 7A-B show contacts630 incorporated therein. FIGS. 7A-B illustrate connector assembly 720including a feedthrough mount 76, which has a cavity 714 for holding aninsulative base 73, and a plurality of feedthrough assemblies 440, aspreviously described, wherein each feedthrough assembly 440 extendsthough a corresponding opening 706 of feedthrough mount 76; thoseskilled in the art will appreciate that mount 76 is formed from anysuitable biocompatible and biostable metal, for example, titanium.Feedthrough member 410, of each feedthrough assembly 440, extendsthrough a corresponding port (not shown) of insulative base 73 andthrough second opening 682 of the corresponding electrical contact 630,which is supported by base 73, to be fixedly coupled, for example, vialaser welding, within second portion 693 of contact coupling receptacle689. FIG. 7B further illustrates each of fastening elements 781extending through a corresponding tab 671, via openings 681 (FIG. 6), inorder to secure contacts 630 to base 73. According to an exemplaryembodiment, fastening elements 781 are formed from protruding posts,which may be integral with base 73; after opening 681 of tab 671 of eachcontact 630 is inserted around the corresponding post, a rivetingoperation, for example, either carried out ultrasonically ormechanically, deforms each post to form the illustrated fasteningelements 781. According to alternate embodiments, pre-formed fasteningelements 781, as individual components, may be inserted throughapertures 681 and into base 73 after each contact is positioned on base73. Opening 681 may have a diameter between approximately 0.005 inch andapproximately 0.015 inch, preferably about 0.010 inch; thus, it may beappreciated that, due to the small size, in addition to an indexingadvantage, posts which are integral with base 73 for forming fasteningelements 781, for example, via riveting, would be preferred overinsertion of individual pre-formed fastening elements 781.

Although not shown in FIG. 7B, it may be appreciated, with reference toFIGS. 7A and 7D, that a sealing member 75 of connector assembly 720 alsofits within cavity 714 of mount 76 and includes apertures 705 in orderto surround each contact 630 to help isolate contacts 630 from oneanother in a manner similar to that previously shown and described fordevice connector assemblies 220 and 320. Sealing member 75 may be formedfrom silicone rubber and base 73 from either polysulfone or PEEK, andsealing member 75 and base 73 may be adhesively bonded to one anothervia the method previously described in conjunction with FIGS. 4A-B.

FIG. 7A illustrates portions of two medical electrical leads 740, whoseconnectors 72 are positioned for coupling within connector assembly 720,and connector assembly 720 further including a lid 787 for securing thecoupling. Each lead connector 72 is shown extending proximally from alead body 74, which, although not shown, may extend distally toterminate in a connector port or in an electrode array, as previouslydescribed for leads 240 and 340, respectively. Lid 787 is shownincluding a relatively rigid outer member 78, for example, formed fromany suitable biocompatible and biostable metal or plastic, and arelatively soft seal member 77, for example, formed from siliconerubber, to seal against a second side 742 of an insulative substrate 702of each lead connector 72, when connector 72 is coupled within deviceconnector assembly 720. Seal member 77 may be attached to outer member78, for example, via a press fit. FIG. 7A further illustrates lid 787including a pair of apertures 712 for mating about a pair of posts 760that extend upward from mount 76 through apertures 732 of both base 73and sealing member 75; an internal surface of each post 760 may includethreads 565 to receive a corresponding fastener 506, whose head may betightened against a corresponding counter-bore 508 of rigid outer member78 of lid 787 in order to secure lid 787 over lead connectors 72.

FIG. 7C is a perspective view of one of lead connectors 72; and FIG. 7Dis a longitudinal section view through a column of contacts 630 indevice connector assembly 720, wherein lead connectors 72 are enclosed,sealed and secured for electrical coupling with contacts 630. FIG. 7Cillustrates insulative substrate 702 of connector 72 having a first side741 from which a plurality of connector elements 700 protrude; eachconnector element 700 includes an approximately cylindrical portion 723and a flange 729 extending laterally therefrom and being embedded ininsulative substrate 702. According to the illustrated embodiment, alongitudinal axis of each approximately cylindrical portion 723 extendsin a direction approximately orthogonal to first side 741 insulativesubstrate 702, and each connector element 700 of lead connector 72 maybe pressed into first portion 683 of electrical coupling receptacle 689of the corresponding contact 630 for electrical coupling as illustratedin FIG. 7D. With reference to FIG. 7D, in conjunction with FIG. 7A, itmay be appreciated that contacts 630, which extend within apertures 705of sealing member 75, are recessed below second surface 752 thereof,such that, when connector elements 700 are coupled in couplingreceptacles 789 and top seal member 77 of lid 787 is secured againstsecond side 742 of connector substrate 702, first side 741 of connectorsubstrate 702 seals against second surface 752 of sealing member 75.Lead connector elements 700, in their entirety or just portions 723thereof, and device electrical contacts 630 may be formed from anysuitable conductive material, examples of which include, withoutlimitation, gold, platinum/iridium, tantalum, titanium, MP35N alloy, andstainless steel. If insulative substrate 702 of connector 72 isrelatively flexible, for example, being formed from silicone rubber orpolyurethane, flanges 729, being formed from any of the aforementionedrelatively rigid and conductive materials, or from a relatively rigidplastic, may lend stability to inserting each cylindrical portion 723into first portion 683 of electrical coupling receptacle 689, forexample, by pressing against second side 742 of substrate 702.

With reference back to FIG. 6A, in conjunction with FIGS. 7B and 7D, itmay be appreciated that two pair of opposing contact surfaces areformed, for coupling with approximately cylindrical portions 723 ofconnector elements 700, by first and second protrusions 601, 602 of eachof first and second sidewalls 631, 632 forming first portion 683 ofcoupling receptacle 689. With further reference to FIG. 7C, it may benoted that, according to some preferred embodiments, approximatelycylindrical portions are slightly tapered from flange 729 to a terminalend 730, which may facilitate insertion thereof into coupling receptacle689. According to some embodiments, a diameter of cylindrical portion723 is in a range from approximately 0.005 inch to approximately 0.012inch. With further reference to FIG. 6, in conjunction with FIGS. 7B and7D, first part 411 of each feedthrough member 410 is shown insertedbetween protrusions 601 and 602 of opposing sidewalls 633, 634 forcoupling within second portion 693 of electrical coupling receptacle 689of the corresponding contact 630. According to some embodiments, adiameter of at least first part 411 of feedthrough member 410 is in arange from approximately 0.005 inch to approximately 0.012 inch.

FIGS. 7A and 7C further illustrate each connector 72 including analignment aperture 707 extending through substrate 702, in proximity toa proximal end 703 of each connector 72; each aperture 707 may be matedwith one of posts 760 of mount 76 in order to help to align eachconnector element 700 with electrical coupling receptacle first portion683 of the corresponding contact 630, thereby facilitating propercoupling of connectors 72 within connector assembly 720, for example, asis illustrated in the section view of FIG. 7D. The plurality of contacts630 are shown divided into two groups of four of contacts 630, whereinthe two groups are arranged as a mirror image of one another, aboutposts 760, in order to accommodate the illustrated end-to-end placementof lead connectors 72. However, it should be noted that alternateembodiments of the present invention are not limited to such anarrangement.

In the foregoing detailed description, the invention has been describedwith reference to specific embodiments. However, it may be appreciatedthat various modifications and changes can be made without departingfrom the scope of the invention as set forth in the appended claims.

1. A medical electrical system comprising: a medical electrical leadincluding a lead body, a plurality of conductors extending within thelead body, and a connector coupled to a proximal end of the lead body,the connector comprising: an insulative substrate including a first sideand a second side; and a plurality of connector elements protruding fromthe first side of the insulative substrate, each connector element ofthe plurality of connector elements coupled to a corresponding conductorof the plurality of conductors; and a medical electrical deviceincluding a housing, electronic circuitry enclosed within the housing,and a connector assembly, the connector assembly comprising: afeedthrough mount joined to the housing and including a cavity; aninsulative base mounted within the cavity of the feedthrough mount; asealing member including a first surface, a second surface, opposite thefirst surface, and a plurality of apertures extending from the firstsurface to the second surface, the first surface being joined to theinsulative base; a plurality of electrical contacts, each contact of theplurality of electrical contacts being supported by the insulative baseand extending within a corresponding aperture of the plurality ofapertures of the sealing member to be accessible for coupling with acorresponding connector element of the plurality of connector elementsof the lead connector, each contact being recessed within thecorresponding aperture with respect to the second surface of the sealingmember; a plurality of feedthrough members, each feedthrough member ofthe plurality of feedthrough members being coupled to a correspondingcontact of the plurality of electrical contacts and extending into thehousing, through the insulative base and the feedthrough mount, tocouple with the electronic circuitry; and a lid including a top sealmember, the top seal member configured to mate with the second surfaceof the sealing member and with the second side of the insulativesubstrate of the lead connector, when the plurality of connectorelements are coupled to the plurality of electrical contacts.
 2. Thesystem of claim 1, wherein the feedthrough mount of the device connectorassembly includes a rigid sidewall surrounding the cavity, and aconnector insertion port extending through a portion of the sidewall,from an exterior to an interior of the cavity.
 3. The system of claim 2,wherein the lid of the device connector assembly is pivotably attachedto the portion of the sidewall of the feedthrough mount through whichthe connector insertion port extends.
 4. The system of claim 2, wherein:the insulative substrate of the lead connector is deformable; and across-sectional area of the connector insertion port of the deviceconnector assembly is sized such that the insulative substrate must bedeformed for insertion therethrough.
 5. The system of claim 1, wherein:the lead connector further includes an aperture extending through theinsulative substrate, from the first side to the second side; and thedevice connector assembly further includes a feature for mating with theaperture of the lead connector.
 6. The system of claim 1, wherein: thelead connector further includes an aperture extending through theinsulative substrate, from the first side to the second side; the deviceconnector assembly further includes a feature for mating with theaperture of the lead connector; the lid of the device connector assemblyfurther includes a securing feature; and the feature of the deviceconnector assembly, for mating with the aperture of the lead connector,is further adapted to mate with the securing feature of the lid, whenthe top seal member of the connector assembly mates with the sealingmember of the connector assembly.
 7. The system of claim 1, wherein: thelead connector further includes an aperture extending through theinsulative substrate, from the first side to the second side; and thedevice connector assembly further includes a post extending away fromthe insulative base of the connector assembly for mating with theaperture of the lead connector.
 8. The system of claim 7, wherein thepost includes threads for mating with a fastener to secure the lid ofthe connector assembly over the sealing member of the connectorassembly.
 9. The system of claim 1, wherein the device connectorassembly further comprises a post extending away from the insulativebase thereof, the post including threads for mating with a fastener tosecure the lid of the connector assembly over the sealing member of theconnector assembly
 10. The system of claim 1, wherein at least onefeedthrough member of the plurality of feedthrough members of the deviceconnector assembly includes a first part coupled to the correspondingcontact of the plurality of contacts, a second part extending throughthe insulative base, and a bend extending between the first part and thesecond part.
 11. The system of claim 1, wherein: at least one connectorelement of the plurality of connector elements of the lead includes anapproximately cylindrical portion having a longitudinal axis extendingin a direction approximately orthogonal to the first side of theinsulative substrate; and at least one electrical contact of theplurality of the electrical contacts corresponding to the at least oneconnector element includes a first pair of opposing contact surfaces anda second pair of opposing contact surfaces, the first and second pairsof opposing contact surfaces adapted to couple the at least oneconnector element to the at least one electrical contact, and the firstpair of opposing contact surfaces being offset from the second pair ofopposing contact surfaces in a direction approximately orthogonal to thelongitudinal axis of the at least one connector element when the atleast one connector element is coupled to the at least one electricalcontact.
 12. A medical electrical system comprising: a first medicalelectrical lead and a second medical electrical lead, each of the firstand second leads including a lead body, a plurality of conductorsextending within the lead body, and a connector coupled to a proximalend of the lead body, each of the connectors comprising: an insulativesubstrate including a first side and a second side; an apertureextending through the insulative substrate, from the first side to thesecond side; and a plurality of connector elements protruding from thefirst side of the insulative substrate, each connector element of theplurality of connector elements coupled to a corresponding conductor ofthe plurality of conductors; and a medical electrical device including ahousing, electronic circuitry enclosed within the housing, and aconnector assembly, the connector assembly comprising: a feedthroughmount joined to the housing and including a cavity; an insulative basemounted within the cavity of the feedthrough mount; a sealing memberincluding a first surface, a second surface, opposite the first surface,and a plurality of apertures extending from the first surface to thesecond surface, the first surface being joined to the insulative base; aplurality of electrical contacts, each contact of the plurality ofelectrical contacts being supported by the insulative base and extendingwithin a corresponding aperture of the plurality of apertures of thesealing member to be accessible for coupling with a correspondingconnector element of the plurality of connector elements of the firstand second lead connectors, each contact being recessed within thecorresponding aperture with respect to the second surface of the sealingmember, and the plurality of electrical contacts being divided into afirst group and a second group, the contacts of the first group beingarranged for coupling with the connector elements of first leadconnector, and the contacts of the second group being arranged forcoupling with the connector elements of the second lead connector; aplurality of feedthrough members, each feedthrough member of theplurality of feedthrough members being coupled to a correspondingcontact of the plurality of electrical contacts and extending into thehousing, through the insulative base and the feedthrough mount, tocouple with the electronic circuitry; a first feature for mating withthe aperture of the first lead connector and second feature for matingwith the aperture of the second lead connector, the first and secondfeatures being located in between the first and second groups of theplurality of electrical contacts; and a lid including a top seal member,the top seal member configured to mate with the second surface of thesealing member and with the second side of the insulative substrate ofeach of the first and second lead connectors, when the plurality ofconnector elements of each of the first and second lead connectors arecoupled to the plurality of electrical contacts. 13.-14. (canceled) 15.The system of claim 12, wherein: the lid of the device connectorassembly further includes a securing feature; and the first and secondfeatures of the device connector assembly, for mating with the aperturesof the first and second lead connectors, are further adapted to matewith the securing feature of the lid, when the top seal member of theconnector assembly mates with the sealing member of the connectorassembly.
 16. The system of claim 12, wherein each of the first andsecond features of the device connector assembly, for mating with theapertures of the first and second lead connectors, comprises a postextending away from the insulative base of the connector assembly. 17.The system of claim 16, wherein each post includes threads for matingwith a fastener to secure the lid of the connector assembly over thesealing member of the connector assembly. 18.-19. (canceled)
 20. Thesystem of claim 12, wherein: each of the first and second leadconnectors further includes a proximal end; and the aperture of each ofthe first and second lead connectors is located in proximity to theproximal end.
 21. A method for coupling a medical electrical leadconnector to a medical electrical device connector assembly, the methodcomprising: orienting a first side of an insulative substrate of thelead connector such that a plurality of connector elements, whichprotrude from the first side of the substrate, face a correspondingplurality of apertures of a sealing member of the device connectorassembly; aligning each connector element of the plurality of connectorelements with a corresponding aperture of the plurality of apertures,after orienting the first side of lead connector; applying a force froma second side of the insulative substrate to press each alignedconnector element of the plurality of connector elements into thecorresponding aperture and into engagement with an electrical contactcoupling receptacle that extends within the corresponding aperture; andsecuring a top seal member over the lead connector, after applying theforce to press each connector element into engagement, such that the topseal member engages the second side of the insulative substrate of thelead connector and the sealing member of the device connector assembly.22. The method of claim 21, further comprising inserting the leadconnector through an insertion port of the device connector assemblyprior to aligning the plurality of connector elements.
 23. The method ofclaim 22, further comprising deforming the insulative substrate of thelead connector prior to inserting the lead connector.
 24. The method ofclaim 22, wherein inserting the lead connector comprises pulling aproximal end of the insulative substrate of the lead connector throughthe insertion port.
 25. The method of claim 21, wherein aligning theplurality of connector elements comprises coupling an alignment featureformed in the insulative substrate of the lead connector with a matingfeature of the device connector assembly.
 26. The method of claim 25,wherein coupling the alignment feature of the lead connector comprisesinserting a post of the device connector assembly through an apertureformed through the insulative substrate of the lead connector.
 27. Themethod of claim 21, wherein securing a top seal member over the leadconnector comprises closing a lid over the lead connector, the top sealmember being attached to the lid.
 28. The method of claim 27, wherein:aligning the plurality of connector elements comprises coupling analignment feature formed in the insulative substrate of the leadconnector to a mating feature of the device connector assembly; andfurther comprising securing the lid to the mating feature.
 29. Themethod of claim 27, further comprising: inserting the lead connectorthrough an insertion port of the device connector assembly prior toaligning the plurality of connector elements; wherein the lid isattached to the device connector assembly in proximity to the insertionport.